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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications.

The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(k)s for devices labeled as sterile that use sterilization methods other than the traditionally used methods of steam, dry heat, ethylene oxide (EO), and radiation.”

And although the agency has experience with other sterilization methods -- such as with hydrogen peroxide, ozone and flexible bag systems, and now considers those to be established methods -- there “may be alterations to the more recently developed methods, as well as original, innovative sterilization technologies, which are being developed and proposed for use in the manufacture of class I and class II devices. FDA considers these to be novel methods.”

Established Sterilization Methods

FDA considers there to be two categories of sterilization methods for medical devices: established and novel.

On the established front, these are methods with a history of safe and effective use as demonstrated through literature, clearances of 510(k)s or approvals of premarket approval (PMA) applications, and satisfactory quality system inspections.

“For established methods such as dry heat, EO, steam, and radiation, there are voluntary consensus standards for development, validation, and routine control that are recognized by FDA,” the agency says.

In cases where FDA has previously evaluated sterilization development and validation data for specific sterilizers and determined the methods to be adequate, the agency says other established methods include: hydrogen peroxide, ozone and flexible bag systems (e.g., EO in a flexible bag system, diffusion method, injection method).

Novel Sterilization Methods

Methods FDA has not reviewed and determined to effectively sterilize a device for its intended use are considered novel and can include using chemical(s) that have not been previously approved by FDA as a chemical sterilant or that have not been identified in the scientific literature as a chemical sterilant.

And the agency notes that even if a sterilization method uses a combination of chemicals made up of individual chemicals previously approved independently, FDA would consider such a method as novel.

The guidance goes on to outline what sponsors should be sure to include in their 510(k) submission, as well this additional information for all novel sterilization methods:

A comprehensive description of the sterilization process;

The method used to validate the sterilization cycle (e.g., the half-cycle method);

The validation protocol;

The sterilization validation data. The submission should also identify any applicable published scientific literature. For novel sterilization methods, FDA may also request additional information based on the specific device submitted for review.

The agency also makes clear to note what should be excluded from this guidance, including: sterilizers that are themselves medical devices subject to 510(k); processes that rely on microbial exclusion, rather than microbial inactivation; processes intended to sterilize medical devices that incorporate materials of animal origin (i.e., human or animal tissues); processes that incorporate the use of liquid chemical sterilants; and processes intended to be used by reprocessors of single-use devices.

The guidance also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission.

On Thursday 11 February, FDA will hold a webinar to help
manufacturers understand the information provided in this final guidance
document. The agency says it will respond to
manufacturers’ questions.